Traditional Chinese medicine for treating protrusion of lumbar intervertebral disc

Abstract

The invention provides a traditional Chinese medicine for treating protrusion of lumbar intervertebral disc, and relates to the technical field of traditional Chinese medicines. Aiming at the core pathogenesis of qi stagnation and blood stasis, deficiency of liver and kidney and cold-dampness arthralgia of the lumbar intervertebral disc protrusion, a synergistic compatibility concept of promoting blood circulation to remove blood stasis, tonifying liver and kidney, dispelling cold-dampness and activating meridians to stop pain is adopted. The traditional Chinese medicine is prepared from 12 traditional Chinese medicines such as ligusticum wallichii, safflower, eucommia ulmoides and radix achyranthis bidentatae through an optimized process of crushing, extracting, concentrating and forming, and the dosage form comprises tablets, capsules or oral liquid. The core innovation lies in accurate matching of the formula, multi-target synergistic effect is achieved, and the problems that traditional Chinese medicine is slow in curative effect and poor in pertinence are solved. Clinical verifications show that the traditional Chinese medicine can relieve lumbar pain within 7 days and improve symptoms such as numbness of lower limbs and limited movement within 1-2 treatment courses, has the total effective rate of greater than or equal to 92%, is safe, has no obvious toxic or side effect, is suitable for patients with different types of lumbar disc herniation, and is convenient to take and high in cost performance.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine for treating lumbar disc herniation. Background Technology

[0002] Lumbar disc herniation is a common orthopedic disease, mainly caused by lumbar disc degeneration, annulus fibrosus rupture, and nucleus pulposus protrusion that compresses nerve roots or cauda equina. Clinical manifestations include lower back pain, radiating pain in the lower limbs, numbness, weakness, and even bowel and bladder dysfunction, which seriously affects the patient's quality of life.

[0003] Current clinical treatment methods include symptomatic treatment with Western medicine, surgical treatment, physical therapy, and traditional Chinese medicine, but they all have many drawbacks: Western medicine treatments (such as nonsteroidal anti-inflammatory drugs and neurotrophic drugs) can only temporarily relieve symptoms. Long-term use can easily cause side effects such as gastrointestinal irritation and liver and kidney damage, and cannot solve the underlying cause. Surgical treatment (such as discectomy) is highly invasive and risky, with a long recovery period and the possibility of recurrence. Some patients still experience residual pain and numbness after surgery. Physical therapy (such as traction and acupuncture) has unstable efficacy, depends on the therapist's experience, and has limited effect on patients with severe protrusions; Traditional Chinese medicine treatments often focus on a single effect (such as simply promoting blood circulation and removing blood stasis or tonifying the liver and kidneys), with weak targeted combinations, slow efficacy, and limited dosage forms that are inconvenient to take, resulting in poor patient compliance.

[0004] In Traditional Chinese Medicine (TCM), lumbar disc herniation falls under the categories of "low back pain" and "Bi syndrome." Its core pathogenesis involves qi stagnation and blood stasis, liver and kidney deficiency, and cold-dampness obstruction. These three factors intertwine, leading to blocked meridians and malnourishment of the muscles and bones. Existing TCM formulas lack a synergistic approach addressing these multiple pathogenesis mechanisms, making it difficult to achieve a comprehensive treatment that addresses both the symptoms and the root cause.

[0005] Therefore, developing a traditional Chinese medicine that is scientifically formulated, has definite efficacy, is safe and convenient, and can simultaneously promote blood circulation, remove blood stasis, tonify the liver and kidneys, dispel cold and dampness, and relieve pain is of great clinical value and market demand. Summary of the Invention (a) Technical problems to be solved

[0006] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine for treating lumbar disc herniation, which solves the problem that existing traditional Chinese medicine formulas lack synergistic consideration of multiple pathogenesis mechanisms and are difficult to achieve both symptomatic and root-cause treatment.

[0007] To achieve the above objectives, the present invention provides the following technical solution: A traditional Chinese medicine for treating lumbar disc herniation, wherein the medicine is made from the following raw materials in parts by weight: 15-25 parts of Ligusticum chuanxiong, 10-20 parts of Carthamus tinctorius, 12-22 parts of Eucommia ulmoides, 10-20 parts of Achyranthes bidentata, 10-20 parts of Taxillus chinensis, 8-18 parts of Angelica pubescens, 3-8 parts of Asarum heterotropoides, 10-20 parts of Angelica sinensis, 8-18 parts of Paeonia lactiflora, 5-15 parts of Boswellia carterii, 5-15 parts of Commiphora myrrha, and 5-10 parts of Glycyrrhiza uralensis. The preparation method of the traditional Chinese medicine includes the following steps: Step 1: Raw material pretreatment After removing impurities, washing and drying the above-mentioned Chinese herbal raw materials, pulverize them to 80-120 mesh to obtain mixed medicinal powder; Step 2: Extraction Add the mixed medicinal powder to 8-12 times the amount of purified water, soak for 30-60 minutes, then extract by decoction 2-3 times, each time for 60-90 minutes, combine the decoctions, and filter to obtain a clear filtrate. Step 3: Concentration The clarified filtrate was concentrated under reduced pressure at 60-70℃ and a vacuum of 0.06-0.08MPa to obtain a thick paste with a relative density of 1.20-1.30 (at 60℃); Step 4: Molding Depending on the dosage form requirements, appropriate excipients are added to the thick paste to make tablets, capsules, or oral liquids, thus obtaining a finished traditional Chinese medicine product for treating lumbar disc herniation.

[0008] Furthermore, the traditional Chinese medicine is made from the following raw materials in parts by weight: 18-22 parts of Ligusticum chuanxiong, 13-17 parts of Carthamus tinctorius, 15-19 parts of Eucommia ulmoides, 13-17 parts of Achyranthes bidentata, 13-17 parts of Taxillus chinensis, 11-15 parts of Angelica pubescens, 4-7 parts of Asarum heterotropoides, 13-17 parts of Angelica sinensis, 11-15 parts of Paeonia lactiflora, 8-12 parts of Boswellia carterii, 8-12 parts of Commiphora myrrha, and 6-9 parts of Glycyrrhiza uralensis.

[0009] Furthermore, the Chinese medicine is made from the following raw materials in parts by weight: 20 parts of Ligusticum chuanxiong, 15 parts of Carthamus tinctorius, 17 parts of Eucommia ulmoides, 15 parts of Achyranthes bidentata, 15 parts of Taxillus chinensis, 13 parts of Angelica pubescens, 6 parts of Asarum heterotropoides, 15 parts of Angelica sinensis, 13 parts of Paeonia lactiflora, 10 parts of Boswellia carterii, 10 parts of Commiphora myrrha, and 7 parts of Glycyrrhiza uralensis.

[0010] Furthermore, the chuanxiong is selected from authentic medicinal materials, and the safflower is selected from dried tubular flowers without ovaries. The two work together to enhance the effects of promoting blood circulation, removing blood stasis, clearing the meridians, and relieving pain.

[0011] Furthermore, the Eucommia ulmoides is selected from salt-processed Eucommia ulmoides, the Achyranthes bidentata is selected from Huai Achyranthes bidentata, and the Loranthus parasiticus is selected from Loranthus parasiticus. The ratio of the three is Eucommia ulmoides: Achyranthes bidentata: Loranthus parasiticus = 1.2:1:1, which synergistically nourish the liver and kidneys, strengthen tendons and bones, and promote blood circulation and unblock collaterals.

[0012] Furthermore, in step two, the water decoction is performed three times: the first time with 12 times the amount of water and decocted for 90 minutes, the second time with 10 times the amount of water and decocted for 75 minutes, and the third time with 8 times the amount of water and decocted for 60 minutes, in order to maximize the extraction of effective components.

[0013] Furthermore, in the molding step, the excipients for preparing tablets include 10-15 parts microcrystalline cellulose, 5-10 parts starch, and 0.5-1 parts magnesium stearate, with a tableting pressure of 8-12 MPa; when preparing capsules, size 0 empty capsules are used, with each capsule containing 0.3-0.5 g; when preparing oral liquids, 0.1-0.3 parts steviol glycosides are added for flavoring, and the pH value is controlled at 5.5-6.5.

[0014] Furthermore, the method of taking the traditional Chinese medicine is as follows: tablets / capsules, 3-4 tablets / capsules 3 times a day, taken with warm water; oral liquid, 10-20mL 3 times a day, taken 30 minutes after meals, for a course of treatment of 30 days.

[0015] Furthermore, the efficacy indicators of the traditional Chinese medicine are as follows: a decrease of ≥30% in the visual analog scale (VAS) score for lower back pain within 7 days of taking the medicine; an improvement rate of ≥80% in lower limb numbness symptoms after 1 course of treatment; a total effective rate of ≥92% after 2 courses of treatment; and no obvious gastrointestinal irritation or toxic side effects.

[0016] Furthermore, the traditional Chinese medicine is suitable for lumbar disc herniation of the qi stagnation and blood stasis type, liver and kidney deficiency type, cold and dampness obstruction type, and mixed type, and can relieve symptoms such as lower back pain, radiating pain in the lower limbs, numbness, and limited mobility.

[0017] This invention provides a traditional Chinese medicine for treating lumbar disc herniation. It has the following beneficial effects: 1. This invention provides a traditional Chinese medicine for treating lumbar disc herniation. The key medicinal materials are selected from authentic varieties, such as Sichuan chuanxiong and Huai achyranthes. Eucommia is processed with salt to enhance its kidney-tonifying effect. The dosage of Asarum is controlled to avoid toxicity, thus balancing efficacy and safety. Targeting the three pathogenesis of lumbar disc herniation, namely "qi stagnation and blood stasis, liver and kidney deficiency, and cold-dampness obstruction", a four-dimensional synergistic formula of "blood-activating + liver and kidney tonifying + cold-dampness dispelling + meridian unblocking" is designed. This formula can activate blood circulation and remove blood stasis, tonify the liver and kidney and strengthen tendons and bones, dispel cold-dampness and unblock meridians, and harmonize the effects of various medicines. It treats both the symptoms and the root cause, solving the problem of the lack of specificity in traditional Chinese medicine.

[0018] 2. This invention provides a traditional Chinese medicine for treating lumbar disc herniation, which uses a three-stage decoction method, scientifically controlling the amount of water added, decoction time and concentration parameters to maximize the extraction of effective components, such as ligustrazine, safflower yellow pigment and eucommia polysaccharide, thereby improving bioavailability.

[0019] 3. This invention provides a traditional Chinese medicine for treating lumbar disc herniation. This traditional Chinese medicine can relieve pain within 7 days, improve core symptoms in 1-2 courses of treatment, and has a total effective rate of ≥92%. It is more than 30% more effective than traditional Chinese medicine. It also supports multiple dosage forms such as tablets, capsules, and oral liquids to meet the different patients' taking habits and improve compliance. Detailed Implementation

[0020] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0021] The formula and compatibility of this traditional Chinese medicine are based on the following: Ligusticum chuanxiong 15-25 parts, Carthamus tinctorius 10-20 parts; Chuanxiong is pungent and warm, and can invigorate blood circulation, promote qi circulation, dispel wind and relieve pain. It is a "qi medicine in the blood" and can unblock the meridians and relieve pain caused by blood stasis and qi stagnation. Honghua is pungent and warm, and can invigorate blood circulation, unblock the meridians and relieve pain. The two work together to enhance the effects of invigorating blood circulation, removing blood stasis, unblocking the meridians and relieving pain, and directly target the core pathogenesis of qi stagnation and blood stasis.

[0022] Eucommia ulmoides 12-22 parts, Achyranthes bidentata 10-20 parts, Taxillus chinensis 10-20 parts; After being processed with salt, Eucommia ulmoides tonifies the kidneys, strengthens the lower back, and fortifies tendons and bones, addressing the malnourishment of tendons and bones caused by liver and kidney deficiency; Achyranthes bidentata tonifies the liver and kidneys, strengthens tendons and bones, and guides blood downwards, directing the medicinal power of the principal herb directly to the affected area of ​​the lower back; Taxillus chinensis dispels wind and dampness, tonifies the liver and kidneys, and strengthens tendons and bones. The three herbs work together to tonify the liver and kidneys, strengthen tendons and bones, and also promote blood circulation and unblock the meridians, assisting the principal herb in treating both the symptoms and the root cause.

[0023] Angelica pubescens 8-18 parts, Asarum sieboldii 3-8 parts, Angelica sinensis 10-20 parts, Paeonia lactiflora 8-18 parts, Boswellia carterii 5-15 parts, Commiphora myrrha 5-15 parts; Angelica pubescens dispels wind and dampness, relieves pain and pain; Asarum dispels wind and cold, clears the orifices and relieves pain (dosage should be controlled to avoid toxicity). Both target the pathogenesis of cold and dampness obstruction. Angelica sinensis nourishes blood, invigorates blood circulation, moistens the intestines and promotes bowel movement; Paeonia lactiflora clears heat, cools blood, disperses blood stasis and relieves pain; Boswellia carterii and Commiphora myrrha invigorate blood circulation, promote qi circulation, relieve pain and reduce swelling. These six adjuvant herbs work together to dispel cold and dampness, enhance the effects of invigorating blood circulation, clearing the channels and relieving pain, while also nourishing blood and avoiding damage to the body's vital energy from invigorating blood circulation.

[0024] 5-10 parts licorice; Licorice is sweet and neutral in nature. It invigorates qi and nourishes the middle jiao, clears heat and detoxifies, harmonizes various medicines, alleviates the irritation of asarum, frankincense, and myrrh, harmonizes the properties of the whole prescription, and reduces toxic side effects.

[0025] Example 1: This invention provides a traditional Chinese medicine for treating lumbar disc herniation, which is made from the following raw materials in parts by weight: 15 parts of Ligusticum chuanxiong, 10 parts of Carthamus tinctorius, 12 parts of Eucommia ulmoides, 10 parts of Achyranthes bidentata, 10 parts of Taxillus chinensis, 8 parts of Angelica pubescens, 3 parts of Asarum heterotropoides, 10 parts of Angelica sinensis, 8 parts of Paeonia lactiflora, 5 parts of Boswellia carterii, 5 parts of Commiphora myrrha, and 5 parts of Glycyrrhiza uralensis.

[0026] The preparation method of this traditional Chinese medicine includes the following steps: Step 1: Raw material pretreatment Cleaning and drying: Quickly rinse all raw materials with pure water to remove surface dust and impurities, and dry them in a 60℃ oven until the moisture content is ≤8%; Pulverization: Pulverize the dried raw materials separately, pass them through a 100-mesh sieve, and then mix them evenly according to the weight ratio of the formula to obtain mixed powder.

[0027] Step 2: Extraction Soaking: Put the mixed powder into the extraction tank, add 12 times the amount of purified water, and soak at room temperature for 45 minutes to fully wet the powder and facilitate the dissolution of the active ingredients; Three decoctions: For the first decoction, heat to a boil and then simmer for 90 minutes, then filter to obtain the first decoction; for the second decoction, add 10 times the amount of purified water to the dregs, boil and then simmer for 75 minutes, then filter to obtain the second decoction; for the third decoction, add 8 times the amount of purified water to the dregs, boil and then simmer for 60 minutes, then filter to obtain the third decoction. Combined filtration: Combine the three decoctions, filter through a 100-mesh filter cloth to remove the dregs, and obtain a clear filtrate.

[0028] Step 3: Concentration The clarified filtrate was transferred to a vacuum concentration tank, and the temperature was set to 65℃ and the vacuum degree to 0.07MPa. The solution was concentrated under reduced pressure to a thick paste with a relative density of 1.25 (at 60℃). The solution was stirred continuously during the concentration process to avoid local overheating that could destroy the active ingredients.

[0029] Step 4: Shaping and tablet making Granulation: Add 12 parts microcrystalline cellulose and 8 parts starch to the thick paste, mix well, form a soft mass, granulate through a 16-mesh sieve, and dry in a 60℃ oven until the moisture content of the granules is ≤5%; Granulation: After drying, the granules are sieved through a 14-mesh sieve to remove coarse particles and fine powder; Tableting: Add 0.8 parts magnesium stearate to the granules, mix evenly, and use a rotary tablet press to compress the tablets at a pressure of 10 MPa to make tablets with a diameter of 6 mm and a weight of 0.4 g. Coating: If coating is required, use film coating materials to improve tablet stability and taste.

[0030] Step 5: Packaging The tablets are tested for disintegration time (≤30 minutes), content uniformity, microbial limits, and other indicators. After passing the tests, they are packaged in aluminum-plastic blister packs, with 12 tablets per blister pack and 10 blister packs per box, and then sealed and stored.

[0031] Example 2: This invention provides a traditional Chinese medicine for treating lumbar disc herniation, which is made from the following raw materials in parts by weight: 18 parts of Ligusticum chuanxiong, 13 parts of Carthamus tinctorius, 15 parts of Eucommia ulmoides, 13 parts of Achyranthes bidentata, 13 parts of Taxillus chinensis, 11 parts of Angelica pubescens, 4 parts of Asarum heterotropoides, 13 parts of Angelica sinensis, 11 parts of Paeonia lactiflora, 8 parts of Boswellia carterii, 8 parts of Commiphora myrrha, and 6 parts of Glycyrrhiza uralensis.

[0032] The preparation method of this traditional Chinese medicine includes the following steps: Step 1: Raw material pretreatment Cleaning and drying: Quickly rinse all raw materials with pure water to remove surface dust and impurities, and dry them in a 60℃ oven until the moisture content is ≤8%; Pulverization: Pulverize the dried raw materials separately, pass them through a 100-mesh sieve, and then mix them evenly according to the weight ratio of the formula to obtain mixed powder.

[0033] Step 2: Extraction Soaking: Put the mixed powder into the extraction tank, add 12 times the amount of purified water, and soak at room temperature for 45 minutes to fully wet the powder and facilitate the dissolution of the active ingredients; Three decoctions: For the first decoction, heat to a boil and then simmer for 90 minutes, then filter to obtain the first decoction; for the second decoction, add 10 times the amount of purified water to the dregs, boil and then simmer for 75 minutes, then filter to obtain the second decoction; for the third decoction, add 8 times the amount of purified water to the dregs, boil and then simmer for 60 minutes, then filter to obtain the third decoction. Combined filtration: Combine the three decoctions, filter through a 100-mesh filter cloth to remove the dregs, and obtain a clear filtrate.

[0034] Step 3: Concentration The clarified filtrate was transferred to a vacuum concentration tank, and the temperature was set to 65℃ and the vacuum degree to 0.07MPa. The solution was concentrated under reduced pressure to a thick paste with a relative density of 1.25 (at 60℃). The solution was stirred continuously during the concentration process to avoid local overheating that could destroy the active ingredients.

[0035] Step 4: Shaping and tablet making Granulation: Add 12 parts microcrystalline cellulose and 8 parts starch to the thick paste, mix well, form a soft mass, granulate through a 16-mesh sieve, and dry in a 60℃ oven until the moisture content of the granules is ≤5%; Granulation: After drying, the granules are sieved through a 14-mesh sieve to remove coarse particles and fine powder; Tableting: Add 0.8 parts magnesium stearate to the granules, mix evenly, and use a rotary tablet press to compress the tablets at a pressure of 10 MPa to make tablets with a diameter of 6 mm and a weight of 0.4 g. Coating: If coating is required, use film coating materials to improve tablet stability and taste.

[0036] Step 5: Packaging The tablets are tested for disintegration time (≤30 minutes), content uniformity, microbial limits, and other indicators. After passing the tests, they are packaged in aluminum-plastic blister packs, with 12 tablets per blister pack and 10 blister packs per box, and then sealed and stored.

[0037] Example 3: This invention provides a traditional Chinese medicine for treating lumbar disc herniation, which is made from the following raw materials in parts by weight: 20 parts of Ligusticum chuanxiong, 15 parts of Carthamus tinctorius, 17 parts of Eucommia ulmoides, 15 parts of Achyranthes bidentata, 15 parts of Taxillus chinensis, 13 parts of Angelica pubescens, 6 parts of Asarum heterotropoides, 15 parts of Angelica sinensis, 13 parts of Paeonia lactiflora, 10 parts of Boswellia carterii, 10 parts of Commiphora myrrha, and 7 parts of Glycyrrhiza uralensis.

[0038] The preparation method of this traditional Chinese medicine includes the following steps: Step 1: Raw material pretreatment Cleaning and drying: Quickly rinse all raw materials with pure water to remove surface dust and impurities, and dry them in a 60℃ oven until the moisture content is ≤8%; Pulverization: Pulverize the dried raw materials separately, pass them through a 100-mesh sieve, and then mix them evenly according to the weight ratio of the formula to obtain mixed powder.

[0039] Step 2: Extraction Soaking: Put the mixed powder into the extraction tank, add 12 times the amount of purified water, and soak at room temperature for 45 minutes to fully wet the powder and facilitate the dissolution of the active ingredients; Three decoctions: For the first decoction, heat to a boil and then simmer for 90 minutes, then filter to obtain the first decoction; for the second decoction, add 10 times the amount of purified water to the dregs, boil and then simmer for 75 minutes, then filter to obtain the second decoction; for the third decoction, add 8 times the amount of purified water to the dregs, boil and then simmer for 60 minutes, then filter to obtain the third decoction. Combined filtration: Combine the three decoctions, filter through a 100-mesh filter cloth to remove the dregs, and obtain a clear filtrate.

[0040] Step 3: Concentration The clarified filtrate was transferred to a vacuum concentration tank, and the temperature was set to 65℃ and the vacuum degree to 0.07MPa. The solution was concentrated under reduced pressure to a thick paste with a relative density of 1.25 (at 60℃). The solution was stirred continuously during the concentration process to avoid local overheating that could destroy the active ingredients.

[0041] Step 4: Shaping and tablet making Granulation: Add 12 parts microcrystalline cellulose and 8 parts starch to the thick paste, mix well, form a soft mass, granulate through a 16-mesh sieve, and dry in a 60℃ oven until the moisture content of the granules is ≤5%; Granulation: After drying, the granules are sieved through a 14-mesh sieve to remove coarse particles and fine powder; Tableting: Add 0.8 parts magnesium stearate to the granules, mix evenly, and use a rotary tablet press to compress the tablets at a pressure of 10 MPa to make tablets with a diameter of 6 mm and a weight of 0.4 g. Coating: If coating is required, use film coating materials to improve tablet stability and taste.

[0042] Step 5: Packaging The tablets are tested for disintegration time (≤30 minutes), content uniformity, microbial limits, and other indicators. After passing the tests, they are packaged in aluminum-plastic blister packs, with 12 tablets per blister pack and 10 blister packs per box, and then sealed and stored.

[0043] Example 4: This invention provides a traditional Chinese medicine for treating lumbar disc herniation, which is made from the following raw materials in parts by weight: 22 parts of Ligusticum chuanxiong, 17 parts of Carthamus tinctorius, 19 parts of Eucommia ulmoides, 17 parts of Achyranthes bidentata, 17 parts of Taxillus chinensis, 15 parts of Angelica pubescens, 7 parts of Asarum heterotropoides, 17 parts of Angelica sinensis, 15 parts of Paeonia lactiflora, 12 parts of Boswellia carterii, 12 parts of Commiphora myrrha, and 9 parts of Glycyrrhiza uralensis.

[0044] The preparation method of this traditional Chinese medicine includes the following steps: Step 1: Raw material pretreatment Cleaning and drying: Quickly rinse all raw materials with pure water to remove surface dust and impurities, and dry them in a 60℃ oven until the moisture content is ≤8%; Pulverization: Pulverize the dried raw materials separately, pass them through a 100-mesh sieve, and then mix them evenly according to the weight ratio of the formula to obtain mixed powder.

[0045] Step 2: Extraction Soaking: Put the mixed powder into the extraction tank, add 12 times the amount of purified water, and soak at room temperature for 45 minutes to fully wet the powder and facilitate the dissolution of the active ingredients; Three decoctions: For the first decoction, heat to a boil and then simmer for 90 minutes, then filter to obtain the first decoction; for the second decoction, add 10 times the amount of purified water to the dregs, boil and then simmer for 75 minutes, then filter to obtain the second decoction; for the third decoction, add 8 times the amount of purified water to the dregs, boil and then simmer for 60 minutes, then filter to obtain the third decoction. Combined filtration: Combine the three decoctions, filter through a 100-mesh filter cloth to remove the dregs, and obtain a clear filtrate.

[0046] Step 3: Concentration The clarified filtrate was transferred to a vacuum concentration tank, and the temperature was set to 65℃ and the vacuum degree to 0.07MPa. The solution was concentrated under reduced pressure to a thick paste with a relative density of 1.25 (at 60℃). The solution was stirred continuously during the concentration process to avoid local overheating that could destroy the active ingredients.

[0047] Step 4: Shaping and tablet making Granulation: Add 12 parts microcrystalline cellulose and 8 parts starch to the thick paste, mix well, form a soft mass, granulate through a 16-mesh sieve, and dry in a 60℃ oven until the moisture content of the granules is ≤5%; Granulation: After drying, the granules are sieved through a 14-mesh sieve to remove coarse particles and fine powder; Tableting: Add 0.8 parts magnesium stearate to the granules, mix evenly, and use a rotary tablet press to compress the tablets at a pressure of 10 MPa to make tablets with a diameter of 6 mm and a weight of 0.4 g. Coating: If coating is required, use film coating materials to improve tablet stability and taste.

[0048] Step 5: Packaging The tablets are tested for disintegration time (≤30 minutes), content uniformity, microbial limits, and other indicators. After passing the tests, they are packaged in aluminum-plastic blister packs, with 12 tablets per blister pack and 10 blister packs per box, and then sealed and stored.

[0049] Example 5: This invention provides a traditional Chinese medicine for treating lumbar disc herniation, which is made from the following raw materials in parts by weight: 25 parts of Ligusticum chuanxiong, 20 parts of Carthamus tinctorius, 22 parts of Eucommia ulmoides, 20 parts of Achyranthes bidentata, 20 parts of Taxillus chinensis, 18 parts of Angelica pubescens, 8 parts of Asarum heterotropoides, 20 parts of Angelica sinensis, 18 parts of Paeonia lactiflora, 15 parts of Boswellia carterii, 15 parts of Commiphora myrrha, and 10 parts of Glycyrrhiza uralensis.

[0050] The preparation method of this traditional Chinese medicine includes the following steps: Step 1: Raw material pretreatment Cleaning and drying: Quickly rinse all raw materials with pure water to remove surface dust and impurities, and dry them in a 60℃ oven until the moisture content is ≤8%; Pulverization: Pulverize the dried raw materials separately, pass them through a 100-mesh sieve, and then mix them evenly according to the weight ratio of the formula to obtain mixed powder.

[0051] Step 2: Extraction Soaking: Put the mixed powder into the extraction tank, add 12 times the amount of purified water, and soak at room temperature for 45 minutes to fully wet the powder and facilitate the dissolution of the active ingredients; Three decoctions: For the first decoction, heat to a boil and then simmer for 90 minutes, then filter to obtain the first decoction; for the second decoction, add 10 times the amount of purified water to the dregs, boil and then simmer for 75 minutes, then filter to obtain the second decoction; for the third decoction, add 8 times the amount of purified water to the dregs, boil and then simmer for 60 minutes, then filter to obtain the third decoction. Combined filtration: Combine the three decoctions, filter through a 100-mesh filter cloth to remove the dregs, and obtain a clear filtrate.

[0052] Step 3: Concentration The clarified filtrate was transferred to a vacuum concentration tank, and the temperature was set to 65℃ and the vacuum degree to 0.07MPa. The solution was concentrated under reduced pressure to a thick paste with a relative density of 1.25 (at 60℃). The solution was stirred continuously during the concentration process to avoid local overheating that could destroy the active ingredients.

[0053] Step 4: Shaping and tablet making Granulation: Add 12 parts microcrystalline cellulose and 8 parts starch to the thick paste, mix well, form a soft mass, granulate through a 16-mesh sieve, and dry in a 60℃ oven until the moisture content of the granules is ≤5%; Granulation: After drying, the granules are sieved through a 14-mesh sieve to remove coarse particles and fine powder; Tableting: Add 0.8 parts magnesium stearate to the granules, mix evenly, and use a rotary tablet press to compress the tablets at a pressure of 10 MPa to make tablets with a diameter of 6 mm and a weight of 0.4 g. Coating: If coating is required, use film coating materials to improve tablet stability and taste.

[0054] Step 5: Packaging The tablets are tested for disintegration time (≤30 minutes), content uniformity, microbial limits, and other indicators. After passing the tests, they are packaged in aluminum-plastic blister packs, with 12 tablets per blister pack and 10 blister packs per box, and then sealed and stored.

[0055] Clinical validation: 120 patients with lumbar disc herniation were selected, including 40 cases of qi stagnation and blood stasis type, 35 cases of liver and kidney deficiency type, 25 cases of cold and dampness obstruction type, and 20 cases of mixed type. They were randomly divided into an observation group (taking the Chinese medicine tablets of this invention) and a control group (taking conventional blood-activating and stasis-removing Chinese medicine tablets), with 60 cases in each group. The results were statistically analyzed.

[0056] Instructions for use: Take once each after breakfast, lunch and dinner daily. One course of treatment is 30 days, and two consecutive courses of treatment are recommended. The statistical results are shown in the table below: Observation indicators Observation group (n=60) Control group (n=60) 7-day pain relief rate (VAS reduction ≥30%) 85.0% 63.3% Improvement rate of lower limb numbness after one course of treatment 83.3% 56.7% Overall effective rate after 2 courses of treatment 93.3% 71.7% Incidence of adverse reactions (gastrointestinal irritation) 3.3% 15.0% The above verification results show that the pain relief rate, symptom improvement rate and total effective rate of the traditional Chinese medicine of this invention are significantly higher than those of the control group, the incidence of adverse reactions is lower, and the advantages of efficacy and safety are more obvious.

[0057] The following points should be noted in this article: 1. The embodiments disclosed herein only relate to the structures involved in the embodiments disclosed herein; other structures may refer to general designs.

[0058] 2. Where there is no conflict, the embodiments of this disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

[0059] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine for treating lumbar disc herniation, characterized in that, The Chinese medicine is made from the following raw materials in parts by weight: 15-25 parts of Ligusticum chuanxiong, 10-20 parts of Carthamus tinctorius, 12-22 parts of Eucommia ulmoides, 10-20 parts of Achyranthes bidentata, 10-20 parts of Taxillus chinensis, 8-18 parts of Angelica pubescens, 3-8 parts of Asarum heterotropoides, 10-20 parts of Angelica sinensis, 8-18 parts of Paeonia lactiflora, 5-15 parts of Boswellia carterii, 5-15 parts of Commiphora myrrha, and 5-10 parts of Glycyrrhiza uralensis. The preparation method of the traditional Chinese medicine includes the following steps: Step 1: Raw material pretreatment After removing impurities, washing and drying the above-mentioned Chinese herbal raw materials, pulverize them to 80-120 mesh to obtain mixed medicinal powder; Step 2: Extraction Add the mixed medicinal powder to 8-12 times the amount of purified water, soak for 30-60 minutes, then extract by decoction 2-3 times, each time for 60-90 minutes, combine the decoctions, and filter to obtain a clear filtrate. Step 3: Concentration The clarified filtrate was concentrated under reduced pressure at 60-70℃ and a vacuum of 0.06-0.08MPa to obtain a thick paste with a relative density of 1.20-1.

30. Step 4: Molding Depending on the dosage form requirements, appropriate excipients are added to the thick paste to make tablets, capsules, or oral liquids, thus obtaining a finished traditional Chinese medicine product for treating lumbar disc herniation.

2. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, The Chinese medicine is made from the following raw materials in parts by weight: 18-22 parts of Ligusticum chuanxiong, 13-17 parts of Carthamus tinctorius, 15-19 parts of Eucommia ulmoides, 13-17 parts of Achyranthes bidentata, 13-17 parts of Taxillus chinensis, 11-15 parts of Angelica pubescens, 4-7 parts of Asarum heterotropoides, 13-17 parts of Angelica sinensis, 11-15 parts of Paeonia lactiflora, 8-12 parts of Boswellia carterii, 8-12 parts of Commiphora myrrha, and 6-9 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, The Chinese medicine is made from the following raw materials in parts by weight: 20 parts of Ligusticum chuanxiong, 15 parts of Carthamus tinctorius, 17 parts of Eucommia ulmoides, 15 parts of Achyranthes bidentata, 15 parts of Taxillus chinensis, 13 parts of Angelica pubescens, 6 parts of Asarum heterotropoides, 15 parts of Angelica sinensis, 13 parts of Paeonia lactiflora, 10 parts of Boswellia carterii, 10 parts of Commiphora myrrha, and 7 parts of Glycyrrhiza uralensis.

4. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, The chuanxiong is selected from authentic medicinal materials, and the safflower is selected from dried tubular flowers without ovaries. The two work together to enhance the effects of promoting blood circulation, removing blood stasis, clearing the meridians, and relieving pain.

5. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, The selected Eucommia ulmoides is salt-processed, the selected Achyranthes bidentata is Huai Achyranthes bidentata, and the selected Loranthus parasiticus is Hu Ji Sheng. The ratio of the three is Eucommia ulmoides: Achyranthes bidentata: Loranthus parasiticus = 1.2:1:1, which synergistically nourish the liver and kidneys, strengthen tendons and bones, and promote blood circulation and unblock collaterals.

6. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, In step two, the water decoction is performed three times: the first time with 12 times the amount of water and decocted for 90 minutes, the second time with 10 times the amount of water and decocted for 75 minutes, and the third time with 8 times the amount of water and decocted for 60 minutes, in order to extract the effective components to the maximum extent.

7. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, In the molding step, the excipients for preparing tablets include 10-15 parts microcrystalline cellulose, 5-10 parts starch, and 0.5-1 parts magnesium stearate, with a tableting pressure of 8-12 MPa; when preparing capsules, size 0 empty capsules are used, with each capsule containing 0.3-0.5 g; when preparing oral liquids, 0.1-0.3 parts steviol glycosides are added for flavoring, and the pH value is controlled at 5.5-6.

5.

8. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, The method of taking the Chinese medicine is as follows: tablets / capsules, 3-4 tablets / capsules 3 times a day, taken with warm water; oral liquid, 10-20mL 3 times a day, taken 30 minutes after meals, for a course of treatment of 30 days.

9. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, The efficacy indicators of the Chinese medicine are: a decrease of ≥30% in the visual analog scale (VAS) score for lower back pain within 7 days of taking the medicine; an improvement rate of ≥80% in lower limb numbness symptoms after 1 course of treatment; a total effective rate of ≥92% after 2 courses of treatment; and no obvious gastrointestinal irritation or toxic side effects.

10. The traditional Chinese medicine for treating lumbar disc herniation according to claim 1, characterized in that, The Chinese medicine described is suitable for lumbar disc herniation of the qi stagnation and blood stasis type, liver and kidney deficiency type, cold and dampness obstruction type, and mixed type. It can relieve symptoms such as lower back pain, radiating pain in the lower limbs, numbness, and limited mobility.